Red blood cell (RBC) transfusions are selected based upon matching donor and recipient blood group: donor and recipient sex are not considered when selecting blood for transfusion. Hence, transfused patients can currently receive sex-matched and/or unmatched RBCs when transfusions are given. Sex-matched stem cell transplants, and some solid organ transplants, have shown that sex-matching donor to recipient improves patient outcomes. Recent exploratory studies have also suggested that patient outcomes could be improved by sex-matching for RBC transfusion. There is emerging evidence of underlying biologic mechanism(s) to support these observations. This study is designed as a randomized controlled trial and will explore the impact on patients who receive RBC transfusions from donors of the same sex ("sex-matched") compared with donors of the opposite sex ("sex-mismatched").
The trial will study adult patients admitted to the Intensive Care Unit who require an RBC transfusion. Patients will be assigned (through a process called randomization) to receive sex-matched RBCs or sex-mismatched RBCs to determine if there is a difference in mortality between those receiving matched versus mismatched RBCs. The results of this trial could have direct implications on resources, blood inventory, and RBC transfusion ordering practices.
Adults (age ≥18);
Admission to a participating ICU;
Requiring RBC transfusion.
Requirement for a specialized RBC product or unit not readily available in inventory (e.g., rare blood type, washed RBCs, complex RBC antibodies, etc.);
Massively bleeding patient (i.e., ≥4 units of blood ordered at one time, or Massive Hemorrhage Protocol initiated, or an urgent blood request made);
Sex unknown or sex other than male or female (i.e. intersex);
Do not have a valid Ontario Health Insurance Plan (OHIP) health card number.
Parallel
Sex-mismatched red blood cell transfusions
Biological/VaccineSex-mismatched red blood cell transfusions
Sex-matched red blood cell transfusions
Biological/VaccineSex-matched red blood cell transfusions
30 day mortality
Death within 30 days of randomization.
30 day in-hospital mortality
In-hospital death within 30 days of randomization.
90 day mortality
Death within 90 days of randomization.
Time to 30 day in-hospital mortality
Time to in-hospital death within 30 days of randomization.
Hemoglobin increment
Lowest hemoglobin post-randomization during ICU admission.
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Michelle Zeller
Lead sponsor
McMaster University
Sponsor institution
Canadian Institutes of Health Research (CIHR)
Collaborator
